Fiducial point optimization

ABSTRACT

A flow rate of blood through an implantable blood pump is determined based on a parameter related to the flow, such as a parameter related to thrust on the rotor of the pump. An amount of current supplied to the pump is used to determine each of a first flow rate value and second flow rate values. Each of the first and second flow rate values, in combination with the parameter related to thrust on the rotor of the pump, are used to calculate a flow rate of blood through the pump.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of patent application Ser. No.15/599,115, filed May 18, 2017 and is a continuation of patentapplication Ser. No. 14/950,213, filed Nov. 24, 2015, now U.S. Pat. No.9,675,742 issued Jun. 13, 2017, entitled FIDUCIAL POINT OPTIMIZATION,and is related to and claims priority to U.S. Provisional ApplicationNo. 62/084,742, filed Nov. 26, 2014, entitled FIDUCIAL POINTOPTIMIZATION, the entirety of which is incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

TECHNICAL FIELD

The present invention relates to blood pumps, to methods of using bloodpumps, and to control circuits adapted for use with blood pumps.

BACKGROUND

Implantable blood pumps may be used to provide assistance to patientswith late stage heart disease. Blood pumps operate by receiving bloodfrom a patient's vascular system and impelling the blood back into thepatient's vascular system. By adding momentum and pressure to thepatient's blood flow, blood pumps may augment or replace the pumpingaction of the heart. For example, a blood pump may be configured asventricular assist device or “VAD.” Where a VAD is used to assist thepumping action of the left ventricle, the device draws blood from theleft ventricle of the heart and discharges the blood into the aorta.

To provide clinically useful assistance to the heart, blood pumps mustimpel blood at a substantial blood flow rate. For an adult humanpatient, a ventricular assist device may be arranged to pump blood atabout 1-10 liters per minute at a pressure differential across the pumpof about 10-110 mmHg, depending on the needs of the patient. The needsof the patient may vary with age, height, and other factors.

It is desirable to monitor the rate at which blood is impelled by ablood pump. For example, if a VAD is operated at a flow rate in excessof the inflow rate of blood to the ventricle, the VAD will create asuction condition within the ventricle, wherein the ventricle iscollapsed and essentially devoid of blood. This condition isundesirable. In this condition, the flow rate through the pump willdecline rapidly. Likewise, if the intake or outlet of the pump isoccluded, the flow rate will decline gradually. If the flow rate throughthe pump declines, either rapidly (e.g., as a result of suctioncondition) or gradually (e.g., as a result of an obstruction orocclusion) to the extent that the flow rate is insufficient, the devicewill not provide sufficient circulatory assistance to the patient.Excessive flow also can create undesirable conditions. Therefore, itwould be desirable to provide a blood pump controller which can monitorthe blood flow rate produced by the blood pump which it controls.

Furthermore, it is preferable to minimize or reduce any errors in theblood flow monitoring process in order to obtain a more accurateestimation of blood flow in the pump. The relationships between certainproperties of the pump (e.g., electrical current supplied to the pump,the speed of rotation of a rotor of the pump, etc.) may be generallyknown and used to predict blood flow rate in the blood pump, such as inthe manner described in co-owned U.S. Published Patent Application No.2012/0245681, entitled “Flow Estimation in a Blood Pump,” the disclosureof which is incorporated herein in its entirety. However, theserelationships are generally estimated, approximated, or otherwisederived from analogous blood pump devices, and in reality may vary frompump to pump. Inaccuracies in the modeling of a pump's characteristiccan in turn lead to inaccuracies in the modeling of flow estimationbehavior for the pump, which in turn may lead to a poor blood flowestimation. Therefore, it is further desirable to provide a blood pumpmonitoring system that is capable of optimizing the parameters that areused to determine blood flow in the pump, thereby minimizing orreducing, errors in the blood flow monitoring process.

SUMMARY

One aspect of the disclosure provides for a method for monitoringoperation of an implantable blood pump, involving, determining an amountof current supplied to the pump, determining a first flow rate value anda second flow rate value based on the amount of current supplied to thepump, and determining a flow rate of blood based on a combination of thefirst and second flow rate values and a weighting parameter such thatthe combination of the first and second flow rate values variesdepending on the weighting parameter. The weighting parameter mayincrease or decrease monotonically over the range of operable flow ratesfor the pump, or over a subset of the range of operable flow rates forthe pump. A weight may be determined and assigned to each of the firstand second flow rate values based at least in part on a relationshipbetween the weighting parameter and a predetermined threshold value. Theassigned weight for the first flow rate value may be inverselyproportionate to the relationship between the weighting parameter andthe predetermined threshold value, and the assigned weight for thesecond flow rate value may be proportionate to the relationship betweenthe weighting parameter and the predetermined threshold value.

Determining the relationship between the weighting parameter and thepredetermined threshold value may involve comparing the differencebetween the weighting parameter and the threshold value to a preselectedspread value. For example, an absolute difference between the weightingparameter and a predetermined threshold value may be calculated, and theabsolute difference may be compared to a predetermined spread value. Insuch an example, determination of the flow rate of blood based on acombination of the first and second flow rate may be limited to when theabsolute difference between the third parameter and a predeterminedthreshold value is less than the predetermined spread value. Forinstance, if the absolute difference is greater than the spread value,and the third parameter is less than the predetermined threshold value,the flow rate of blood may be determined based on the first flow ratevalue and not the second flow rate value. Additionally, oralternatively, if the absolute difference is greater than the spreadvalue, and the third parameter is greater than the predeterminedthreshold value, the flow rate of blood may be determined based on thesecond flow rate value and not the first flow rate value. Similarly, ifthe absolute difference is greater than the spread value, the thirdparameter is less than the predetermined threshold value, and adetermined speed of rotation of the rotor is greater than a thresholdspeed value to which the determined speed is compared, the flow rate ofblood may be determined based on the first flow rate value; but if thedetermined speed is less than the threshold speed value, the flow rateof blood may be determined based on the third parameter and neither ofthe first and second flow rate values.

In some examples, the implantable blood pump may include a housinghaving an axis and a rotor disposed within the housing and rotatablearound the axis. The weighting parameter may be related to thrust on therotor along the axis.

Another aspect of the present disclosure provides for a control circuitfor monitoring the operation of an implantable blood pump. The controlcircuit may include a current determination circuit operative todetermine an amount of current supplied to the pump, a flow rate valuedetermination circuit operative to determine a first flow rate value anda second flow rate value based on the amount of current supplied to thepump, a transformation circuit operative to determine a weightingparameter, and a flow rate determination circuit operative to determinea flow rate of blood through the pump based on a combination of thefirst and second flow rate values and the weighting parameter.

Yet another aspect of the present disclosure provides for an implantableblood pump system including a pump with a housing having an axis, and arotor disposed within the housing, the rotor being rotatable around theaxis, and further including the above described control circuitoperatively coupled to the pump. The pump may further include a statoroperatively coupled to the control circuit. The stator may incorporate aplurality of coils for applying a rotating magnetic field to the rotor,and the weighting parameter may be based on back electromotive force(BEMF) in one or more of the plurality of coils.

Yet a further aspect of the present disclosure provides for a method ofoptimizing an estimate of flow rate of blood through an implantableblood pump. The method may involve measuring the flow rate of bloodthrough the implantable blood pump, estimating the flow rate of bloodthrough the implantable blood pump based at least in part on a firstparameter related to thrust on the rotor along the axis and a secondparameter selected from one of a threshold value and a spread value,determining a difference between the measured flow rate and theestimated flow rate, and adjusting the second parameter based on thedetermined difference such that estimating the flow rate of blood basedon the adjusted second parameter results in a reduced difference betweenthe measured flow rate and the estimated flow rate. The estimating,determining, adjusting, and optionally measuring, steps may continuerepeatedly only if the determined difference between the measured flowrate and the estimated flow rate is not less than a threshold errorvalue.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a schematic, partially sectional view of a blood pump systemin accordance with one embodiment of the invention;

FIG. 2 is a diagrammatic sectional view taken along line 2-2 in FIG. 1;

FIG. 3 is a partially functional block diagrammatic, partially sectionalview of the blood pump system of FIG. 1;

FIG. 4 depicts a plot of voltage sampled across a coil in a stator ofthe blood pump of FIGS. 1-3;

FIG. 5 is a schematic diagram showing the hardware and software used inthe blood pump system of FIG. 1-3;

FIG. 6 is a graph depicting certain relationships in operation of theblood pump system of FIGS. 1-3;

FIG. 7 depicts a flowchart of a method of operation used by the systemof FIGS. 1-3;

FIGS. 8 and 9 are detail flowchart depicting portions of the method FIG.7; and

FIG. 10 is a partial block diagrammatic, partial sectional view of ablood pump system in accordance with another embodiment of theinvention.

DETAILED DESCRIPTION

FIGS. 1-3 depict a blood pump system 100 in accordance with oneembodiment of the invention. The blood pump system 100 according to thisembodiment includes a control circuit 140 connected via a cable feed 150to a blood pump 101. The blood pump 101 includes a housing 110 defininga bore 112 having an axis A. A rotor 120 is disposed within the bore.The rotor 120 has a permanent magnetization with flux directionperpendicular to the axis of the bore. The rotor constitutes an impellerconfigured to push blood in a downstream direction D parallel to thebore 112 when the rotor is turning.

The pump also includes a stator 130. The stator includes coils 132 a-e(FIG. 2) connected in a WYE or delta configuration and placed around thecircumference of the housing 110. The coils are arranged in pairsdiametrically opposed to one another. Thus, coils 132 a and 132 b formone pair, coils 132 c and 132 d form another pair, and coils 132 e and132 f form another pair. When the coils are driven using a 3-phasecurrent, they provide a magnetic field directed transverse to the boreaxis and which rotates around the axis. The magnetic field will interactwith the magnetic field of the rotor 120 causing the rotor to turn. Inoperation, the rotor 120 may be suspended within the bore 112 bymagnetic forces, hydrodynamic forces, or both in combination. Desirably,these forces support the rotor so that it does not contact housing 110during normal operation. Further details about suspended-rotor bloodpumps, such as the pump 101, are provided in U.S. Published PatentApplication No. 20070100196, entitled “Axial Flow Pump withMulti-Grooved Rotor,” the disclosure of which is incorporated herein byreference.

The control circuit 140 comprises driver circuit 310, currentdetermination module 320, and speed determination module 330. BEMFmeasuring module 340, transformation module 350, flow determinationmodule 360, and pump control module 370. The modules are depicted anddiscussed with reference to their individual functions. One or more ofthe modules 310-270 may be implemented using software operating in acomputer system including a general-purpose or special purposeprocessor, in digital circuitry, or in using analog circuitry.

The driver circuit 310 is an electrical circuit for powering the pump101 with a 3-phase current. Each phase of the three-phase currentpreferably is in the form of a generally rectangular wave includingalternating off or “open-phase” periods in which power is not applied bythe drive circuit and on or “closed-phase” periods during which power isapplied. The periods of the various phases are arranged so that at anymoment, two pairs of coils are on or closed-phase and one pair is off oropen-phase. The open-phase and closed-phase periods of the variousphases are arranged so that the various pairs of coils go to anopen-phase state in sequence, thus creating the rotating magnetic fieldthat actuates the rotor. Driver circuit 310 applies pulse widthmodulation during each on or closed-phase period. Thus, during each onor closed-phased period, the voltage applied to the pair of coils variesrepeatedly between zero and a selected maximum value at a pulsemodulation or chopping frequency much higher than the frequency of therectangular waveform of the repeating closed-phase and open-phaseperiod.

For example, FIG. 4 depicts the voltage across coil pair 132 a and 132b. During each on or closed-phase period 410 and 430, the voltageapplied by the drive circuit is repeatedly chopped or pulse-widthmodulated. During open-phase periods 420 and 440, the coils 132 a and132 b are not energized by the driver circuit 310. During the open-phaseperiods, a relatively small voltage appears across coils 132 a and 132b. This voltage is composed primarily of voltage induced in the coilpair 132 a and 132 b by the rotating magnetic rotor 120. This inducedvoltage is referred to as the back electromagnetic force of “BEMF.” TheBEMF varies in a generally sinusoidal manner; the open periodscorrespond to the zero-crossings of the sinusoidal variation. Thevoltage appearing on the coil pair during the open periods also includessome higher-frequency components representing voltage induced in pair132 a and 132 b by the fluctuating pulse-width modulated currents in theother coil which are in the closed-phase or on state. During the openperiods 420 and 440, the voltage across coil pair 132 a and 132 b isless than a given threshold (e.g., +/−0.5V).

Returning to FIG. 3, the current determination module 320 may includehardware and/or software for determining the amount of current suppliedto the pump 101. For example, the current determination module mayinclude a known resistance in series with coil pair 132 a and 132 b, andan analog-to-digital converter arranged to sample the voltage across theknown resistance so that each such sample represents the instantaneouscurrent passing through the coil pair, as well as an averaging circuitarranged to average these samples to provide a measure of the averagecurrent passing through the coil pair.

The control circuit further includes a voltage sampling circuit 315. Thevoltage-sampling circuit may include an analog-to-digital converterconnected across coil pair 132 a and 132 b and arranged to capturesuccessive samples of the voltage appearing across the coil pair. Thevoltage-sampling circuit may also include a digital filter forsuppressing variations in the sampled voltage at frequencies at or abovethe pulse-width modulation or chopping frequency used by the drivecircuit, so as to provide a filtered series of values. Alternatively,the sampling circuit may include an analog low-pass filter connectedbetween the analog-to-digital converter and the coil pair.

A speed determination module 330 is operatively connected to thesampling circuit 315 to receive the filtered values from samplingcircuit. The speed determination module is arranged to deduce the speedof rotation of the magnetic field, and hence the speed of rotation ofrotor 120, from these values. For example, the speed determinationmodule may be arranged to record the time when the voltage on coil pair132 a and 132 b drops below the threshold value associated with theopen-phase periods as the beginning of an open-phase period, and tocalculate the interval between the beginnings of successive open-phaseperiods. The speed of rotation is inversely proportional to this time.

The BEMF measuring module 340 is also connected to receive the stream ofsampled voltage values from sampling circuit 315, and to record thefiltered voltage values during the open-phase periods. These filteredvalues represent the BEMF generated by the pump. Transformation module350 is connected to BEMF measuring module 340. The transformation moduleprocesses the data collected by the BEMF measuring module 340 todetermine a value of a function of the BEMF. The function is referred toherein as F(BEMF). F(BEMF) may be rate of change of the BEMF withrespect to time during each open-phase period, i.e., the absolute valueof the slope of the BEMF versus time. Like the BEMF measuring module340, the transformation module 350 may also be implemented usinghardware and/or software.

The flow determination module 360 may include hardware and/or softwarefor determining the rate at which blood is impelled by the pump 101. Theflow determination module is operatively connected to currentdetermination module 320, speed determination module 330 andtransformation module 350 so that the flow determination module 360receives values representing current, speed and F(BEMF). The flowdetermination module is arranged to determine the flow rate from thepump based on this information as further discussed below. Pump controlmodule 370 is operatively linked to flow determination module 360 sothat the pump control module 370 receives values representing the flowrate from the flow determination module. The pump control module is alsolinked to driver circuit 310. The pump control module is arranged todetermine a desired pump speed based, at least in part, on the flow rateand to command driver circuit 310 accordingly. Thus, the pump controlmodule can control the pump 100 based on the blood flow rate determinedby the flow determination module 370 as further discussed below.

In operation, the control circuit 140 powers the pump 101, via thedriver circuit 310, thereby causing the rotor 120 to spin. As the rotor120 spins, blood enters the pump 101 through the inflow end 380 afterwhich the blood is impelled by the rotor 120 from the outflow end 390.As the blood passes through the pump 101, it imparts a thrust on therotor 120. The magnitude of this thrust is related to the flow rate ofblood through the pump.

As discussed above, the rotor 120 is held in position by magnetic andhydrodynamic forces. However, these forces do not hold the rotor withinfinite rigidity. Therefore, thrust imparted to the rotor 120 causesthe rotor 120 to move by a displacement distance D towards the inflowend 380. For at least some range of thrust values, distance D is relatedto the magnitude of the thrust and, thus, related to the blood flowrate. Distance D is greatly exaggerated in FIG. 3 for clarity ofillustration; in practice, distance D is small in comparison to thedimension of the rotor and pump. Axial displacement of rotor 120 alsochanges the alignment between the rotor and the coils 132 of the pump.This alters the magnetic interaction between the rotor and the coils ofthe stator, and thus alters the BEMF. The effect of this alteration willdepend, inter alia, on the alignment between the rotor and the coilsunder zero-thrust conditions and on the configuration of the rotor andthe coils. However, for any particular pump operating at a particularspeed with blood of a particular viscosity, the effect is repeatable andpredictable. The relationship between BEMF and flow rate at one pumpspeed and blood viscosity for the pump of FIGS. 1-3 is shown by curve620 in FIG. 6. In the particular embodiment of FIGS. 1-3, the BEMFincreases with increasing blood flow rate at least in the range betweenzero and a flow rate T. Although the present invention is not limited byany theory of operation, it is believed the thrust on the rotor is acomposite of reaction components directed upstream toward the inlet endof the pump and viscous components directed downstream toward the outletend. At zero flow, the reaction components predominate and thus thethrust is directed upstream. As the flow rate increases from zero, theviscous components increase and thus the magnitude of the thrustdecreases. As the thrust decreases, distance D decreases and the rotormoves into better alignment with the coils, so that BEMF increases.

Because F(BEMF) (the rate of change in BEMF in the open phase period) isproportional to BEMF, the same curve 620 depicts the relationshipbetween F(BEMF) and the blood flow rate. Stated another way. F(BEMF) isa parameter related to the thrust on the rotor. The flow determinationmodule 360 determines the flow rate of blood through the pump based inpart on this parameter as further explained below. As also shown in FIG.6, the current consumed by the pump also varies with flow rate. Curve610 depicts the variation of current with flow rate at a particular pumpoperating speed. The flow determination module 360 uses both current andF(BEMF) to determine the flow rate. In brief, the flow determinationmodule uses the value of F(BEMF) and the relationship between F(BEMF)and flow rate to derive an initial estimate of flow rate. If thisinitial estimate indicates that the flow rate is significantly below avalue M referred to herein as the “fiducial” flow value, the flowdetermination module uses the value of current and the relationshipbetween current and flow rate indicated in the left region of curve 610to determine the flow rate. If the initial estimate of flow rateindicates that the flow rate is significantly above the fiducial valueM, the flow determination module uses the value of the current and therelationship between current and flow rate indicated in the right regionof curve 610 to determine the flow rate. If the initial estimate of flowrate indicates that the flow rate is neither significantly above norsignificantly below the fiducial value M, such that there is a degree ofuncertainty as to which of the left and right regions of curve 610should be used to determine the flow rate, the flow determination moduleuses a combination of flow rates determined from the left and rightregions of curve 610 to determine the flow rate.

The various modules discussed above with reference to FIG. 3 desirablyare implemented at least in part by a general-purpose processor whichperforms functions associated with the various modules. FIG. 5 depictsthis implementation. As shown, the control circuit 140 is implementedusing a processor 510, a memory 520, data 530, instructions 540, and aninterface 550. Memory 520 stores information accessible by processor510, including instructions 540 that may be executed by the processor510. The memory also includes data 530 that may be retrieved,manipulated or stored by the processor. The memory may be of any typecapable of storing information accessible by the processor, such as ahard-drive, memory card, ROM, RAM, DVD, CD-ROM, write-capable, andread-only memories. The processor 510 may be any well-known processor,such as commercially available processors. Alternatively, the processormay be a dedicated controller such as an ASIC.

Data 530 may be retrieved, stored or modified by processor 510 inaccordance with the instructions 540. The data may also be formatted inany computer-readable format such as, but not limited to, binary values,ASCII or Unicode. Moreover, the data may comprise any informationsufficient to identify the relevant information, such as numbers,descriptive text, proprietary codes, pointers, references to data storedin other memories (including other network locations) or informationthat is used by a function to calculate the relevant data.

A current-to-flow table 532 is a tabular representation of the function610 depicted in FIG. 6. The current-to-flow table 532 may identify oneor more blood flow rates that result when a given amount of current isused to power the pump 101. An example of a current-to flow table 532 isprovided as Table 1. As shown in FIG. 6, the relationship 610 betweencurrent and flow is not a single-valued function. Curve 610 illustrates,for instance, that when C amperes are used to power the pump 101, thepump 101 may impel blood at either F₁, L/min or F₂, 2 L/min. In otherwords, the plot illustrates that in this embodiment, there is amany-to-one mapping between current and blood flow rate. As also shownby curve 610, the relationship is such that for any flow in the leftregion of the current-to-flow relationship, below the fiducial value Mliters/minute, there is a one-to-one mapping between current and flow.At any flow above the fiducial value M liters/minute, there is adifferent one-to-one mapping between current and flow.

Thus, as depicted in Table 1, the current-to-flow map stores pluralvalues of flow rate for each value of current, one associated with theleft region and one associated with the right region. At a value ofcurrent corresponding to the fiducial flow rate (1.0 amps in the exampleof Table I), the two values are the same; the current-to-flow table 532indicates that when the pump 101 is powered with 1.0 amps of current, itpumps blood at the rate of 2 L/min. At a current of 1.2 amps, the bloodflow rate is either 1.5 L/min or 3.0 L/min. The current-to-flowrelationship varies with the speed of operation of the pump, i.e., therotation rate of the rotor. The current-to-flow relationship also varieswith viscosity of the blood. The viscosity of the blood is directlyrelated to the hematocrit, i.e., the proportion of the blood volumeoccupied by red blood cells. Therefore, the current-to-flow table storesdifferent sets of values, each associated with a range a particular pumpoperating speed and blood viscosity. Sets of values for other pumpoperating speeds and viscosities are calculated from the stored sets byinterpolation. The flow calculation module selects the appropriate setof values based on the speed of operation of the pump and on a value ofhematocrit or blood viscosity for the patient which has been supplied tothe system from an external source through interface 550. Thecurrent-to-flow table 532 may be implemented as a file, a datastructure, as part of a database, or in any other suitable form.

TABLE 1 Current-to-Flow Map Blood Flow Rate Blood Flow Rate Current FlowRate Left Region Right Region 1.0 amps 2.0 L/min 2.0 L/min 1.2 amps 1.5L/min 3.0 L/min 1.4 amps 1.0 L/min 4.0 L/min

F(BEMF)-to-flow table 534 may be a tabular representation of thefunction 620 depicted in FIG. 6. The F(BEMF)-to-flow table 534identifies the flow rate of blood impelled by the pump 101 when theF(BEMF) indicates that the BEMF in coil pair 132 a and 132 b changes ata given rate with respect to time. The BEMF-to-flow relationship alsochanges with pump operating speed and viscosity, i.e., hematocrit.Therefore, table 534 includes different sets of data, each associatedwith a given speed of rotation of the rotor 120 and a given viscosity.Here again, values for pump operating speeds and blood viscosities notrepresented in the stored data are derived by interpolation.

An example of the F(BEMF)-to flow table 534 is provided as Table 2.According to this example, the BEMF-to-flow table 534 indicates thatwhen the BEMF in the coil 132 a changes at the rate of 5.5 V/s, the pump101 impels blood at the rate of 2.5 L/min. The BEMF-to-flow table 534may be implemented as a file, a data structure, as part of a database,or in any other suitable form.

TABLE 2 BEMF-to-Flow Map F(BMEF) Blood Flow Rate (@ 10000 rpm) 0.2 V/s0.75 L/min  0.4 V/s 1.5 L/min 0.5 V/s 2.0 L/min 0.55 V/s  2.4 L/min 0.60V/s  2.5 L/min

Fiducial BEMF values 536 for a given pump are also included with thedata 530. The fiducial BEMF values 536 provide an indication as towhether the flow determination module should use the relationshipbetween current and flow rate indicated in the left region or rightregion of curve 610 (FIG. 6), as well as a degree of certainty of suchindication. The fiducial midpoint T is the value of F(BEMF) that relatesto the flow rate in between the left and right regions of curve 610. Thefiducial midpoint is centered in a range of F(BEMF) values referred toherein as a fiducial band. The fiducial band covers a range of values ofF(BEMF) that are considered to be neither significantly less than orsignificantly greater than the fiducial midpoint T. Spread S is definedas half of the fiducial band. In other words, spread S equals theabsolute difference between the fiducial midpoint T and either of themaximum F(BEMF) value and minimum F(BEMF) value within the fiducialband. As with tables 532 and 534, the fiducial BEMF values 536 may beimplemented as a file, a data structure, as part of a database, or inany other suitable form.

The data may be determined experimentally using the actual pump or asample pump of similar configuration. In addition, each of the tablesmay be pre-loaded in the memory 520 before the pump 101 is deployed.With respect to the fiducial BEMF values, these values may also bepre-loaded in the memory 520. The pre-loaded values may be subsequentlyoptimized using the optimization protocol described in greater detailbelow.

The instructions 540 may be instructions to be executed directly (suchas machine code) or indirectly (such as scripts) by the processor. Inthat regard, the terms “instructions,” “steps” and “programs” may beused interchangeably herein. The instructions may be stored in objectcode format for direct processing by the processor, or in any othercomputer language including scripts or collections of independent sourcecode modules that are interpreted on demand or compiled in advance.Functions, methods and routines of the instructions are explained inmore detail below. Flow estimation module 542 may include instructionsfor determining the blood flow rate produced by the pump 101 as furtherexplained below, whereas pump control module 544 may includeinstructions for controlling the operation of the drive circuit 310(FIG. 3) and thus controlling pump 101. The operations according toinstructions 540 is further discussed below with respect to FIG. 7.

The control circuit 140 may optionally include an interface 550 whichconnects the control circuit 140 to an output device 560. The interface550 may be an analog interface (e.g., audio interface) or a digitalinterface, such as Bluetooth. TCP/IP, 3G, and others. Where the controlcircuit is implemented in an implantable structure adapted to bedisposed within the body of the patient, the interface 550 may includeknown elements for communicating signals through the skin of thepatient. The output device 560, may be a speaker, a communicationsterminal (e.g., computer, cell phone) or any other type of device.

Although FIG. 5 functionally illustrates the processor and memory asbeing within the same block, it will be understood that the processorand memory may actually comprise multiple processors and memories thatmay or may not be stored within the same physical housing. The memorymay include one or more media on which information can be stored.Preferably, the medium holding the instructions retains the instructionsin non-transitory form. Some or all of the instructions and data may bestored in a location physically remote from, yet still accessible by,the processor. Similarly, the processor may actually comprise acollection of processors which may or may not operate in parallel.

FIG. 7 depicts a flowchart of a process 700 for determining the rate atwhich blood is impelled by the pump 101. At task 710, the controlcircuit 140 determines the amount of current that is used to power thepump 101.

At task 720, the control circuit determines a parameter related tothrust imparted on the rotor 120 by the flow of blood exiting the pump101. In this embodiment, the determined parameter is the functionF(BEMF), the rate of change of BEMF during the open phase periods ofcoil pair 132 a and 132 b as discussed above. FIG. 8 depicts thesub-steps of step 720. To determine the F(BEMF), the control circuit 140first samples voltage across the coil pair 132 a and 132(b). In oneembodiment, for example, the sampling frequency may be 200 kHz (task810). The samples may then be filtered using an average filter. Forexample, the filter may be specified asVout[i]=K*Vin[i]+(1−K)*Vout[i−1], where 0≤K≤1 (task 820). The controlcircuit 140 then identifies an open phase period. In some aspects theopen-phase period based on the voltage levels of the sampled signalbeing under a predetermined threshold (task 830). Once one or moreopen-phase periods are identified, the control circuit 140 determinesthe voltage across the coil 132 a during the identified open-phaseperiods. The determined voltage is the BEMF (task 840). The controlcircuit calculates F(BEMF), the rate of change in BEMF from the BEMFvalues during the open-phase periods (task 850). The rate of change maybe measured using any number of voltage samples (e.g., 2, 20, 200) takenat any sampling frequency (e.g., 200 kHz). Desirably, calculation ofF(BEMF) occurs in real time.

At task 730, (FIG. 7) the control circuit 140 determines the speed ofrotation of the rotor 120. As discussed above the control circuitsamples voltage across the coil pair 132 a and 132 b, identifiesopen-phase periods in which the voltage appearing across the coil isless than a threshold voltage, and determines the number of theopen-phase periods per unit time or, equivalently, the time betweensuccessive open-phase periods for a particular coil. The control circuitdetermines the speed based on this measurement. The greater the numberof open-phase periods per unit time, or the lesser the time betweensuccessive open-phase periods, the faster the speed.

At task 740, the control circuit 140 determines the rate at which bloodis impelled by the pump 101 based on the parameter related to thrustdetermined at task 720.

The tasks included in task 740 are shown in greater detail in FIG. 9. Attask 910, the control terminal retrieves a function that maps the BEMFslope to a blood flow rate, i.e., F(BEMF)-to-flow table 534 (FIG. 5 andTable II, above), for the speed at which the pump is operating. At task920, the control circuit 140 retrieves one or more parameters thatdefine the relationship between the determined F(BEMF) and a fiducialvalue M of flow rate, i.e., fiducial BEMF parameters 536 (FIG. 5). Attask 930, the control circuit 140 determines the relative weight W %assigned to each of the left and right blood flow rate values of thecurrent-to-flow table (FIG. 5 and Table I, above). The weight of a flowrate value provided in the current-to-flow table is in part based on therelative certainty that the pump is operating on the left or rightregion of curve 610. This relative certainty may be calculated using thefollowing formula:

$\begin{matrix}{{W\mspace{14mu} \%} = \frac{{F({BEMF})} - \left( {T - S} \right)}{2S}} & {{Formula}\mspace{14mu} 1}\end{matrix}$

where F(BEMF) is the value of F(BEMF) determined in task 720, and T andS are the respective fiducial BEMF values 536. Depending on therelationship between the BEMF value, T and S, W % may equal more than 1,less than 0, or between 0 and 1. For example, for values of F(BEMF) thatexceed than the range of values within the fiducial band, W % equalsmore than 1. For values of BEMF that are less than the range of valueswithin the fiducial band, W % is less than 0. For values of F(BEMF)within the fiducial band, W % equals between 0 and 1, and increaseslinearly proportionately with F(BEMF).

At task 940, the control circuit 140 retrieves the function 610 thatmaps an amount of current supplied to the pump 101 to blood flow ratethat is generated by the pump 101, i.e., the current-to-flow table 532(FIG. 5 and Table 1, above).

At task 950, the control circuit 140 determines which of two differenttasks to execute based on the value of W %. The first task 960determines a first blood flow rate value based on the left portion ofthe function 610. The second task 970 determines a second blood flowrate value based on the right portion of the function 610. These tasks960 and 970 are described in greater detail below. A value of W % thatis less than 0 indicates with relative certainty that the correct bloodflow rate value is on the left portion of the function 610; therefore,only task 960 is executed by the control circuit. A value of W % that isgreater than 1 indicates with relative certainty that the correct bloodflow rate value is on the right portion of the function 610; therefore,only task 970 is executed by the control circuit. A value of W % that isbetween 0 and 1 indicates that the correct blood flow rate value may beeither on the left or on the right portion of the function 610;therefore, both tasks 960 and 970 are executed.

At task 960, in order to determine a first blood flow rate value basedon the left portion of the function 610, the control circuit 140 may usethe value of current as an index and retrieve the corresponding value offlow from the entries in the current-to-flow table 532 (and Table 1,above) that pertains to the left portion. Alternatively, the controlcircuit 140 may obtain two or more values that correspond to the sameamount of current and then select the smallest one. In either process,standard interpolation techniques can be used when the value of currentfalls between stored values.

At task 970, in order to determine a second blood flow rate value basedon the right portion of the function 610, the control circuit 140 mayuse the value of current as an index and retrieve the correspondingvalue of flow from the entries in the current-to-flow table 532 (andTable 1, above) that pertain to the right portion. Alternatively, thecontrol circuit 140 may obtain two or more values that correspond to thesame amount of current and then select the largest one. In eitherprocess, standard interpolation techniques can be used when the value ofcurrent falls between stored values.

Q _(T)=[(1 −W%)*Q ₁]+[W%*Q ₂]  Formula 2:

where Q₁ is the first blood flow rate value (task 960) and Q₂ is thesecond blood flow rate value (task 970), to determine Q_(T), which isthe determined flow rate (task 980). In the example of Formula 2, thecontrol circuit may use fuzzy logic to weigh the first and second bloodflow rate values against one another. The weights attributed to both Q₁and Q₂ are adjusted proportionate to the value of W % (inverselylinearly for Q₁, linearly for Q₂). Thus, Q₁ is attributed a greaterweight than Q₂ for values of F(BEMF) that are less than T (but greaterthan T−S), and Q₂ is attributed a greater weight than Q₁ for values ofF(BEMF) that are greater than T (but less than T+S).

The above calculations for determining flow rate are meant as an exampleand may performed in any particular order or dividing into any number ofsteps. For instance, the control circuit 140 may first compare F(BEMF)to an absolute difference between T and S (|T−S|). When |T−S| is greaterthan F(BEMF), W % percent is either greater than 1 (for values of Sgreater than T) or less than 0 (for values of T greater than S). Undersuch circumstances, the control circuit may proceed with either task 760(for T>S) or task 770 (for S>T) without calculating W % or Q_(T).Otherwise, the control circuit performs both task 760 and 770, andcalculates W % and Q_(T).

At task 750 (FIG. 7), the control circuit 140 controls the operation ofthe pump 101 or takes other action in response to the determined flowrate. For example, the control circuit may maintain a set point for theflow rate and a moving average of the flow rates as determined over apreset period as, for example, a few minutes. The flow rate set pointmay be a fixed value or a value determined on the basis of physiologicalparameters such as the patient's heart rate, respiratory rate or bloodoxygen level. If a new value of flow rate is below the moving average bymore than a predetermined amount, this may indicate either that the pumphas created a suction condition at the intake, or that the outlet of thepump is blocked. For example, where the pump is drawing blood from theleft ventricle, a suction condition may arise where the intake of thepump is positioned so that as the heart beats, the opening of the intakecomes to rest against the wall of the ventricle and the opening isblocked. In this situation, the flow rate may fluctuate as the beatingmotion of the heart periodically blocks and unblocks the intake. Bycontrast, where the outlet of the pump is blocked, the flow ratetypically will remain at a low value without such fluctuations. Thecontrol circuit can differentiate between such a suction condition and acontinual blockage of the pump.

The determined flow rate may also, or alternatively, be used to optimizethe pre-loaded fiducial F(BEMF) values for the fiducial midpoint andspread. Often, the pre-loaded fiducial F(BEMF) values are estimatesdetermined during development of the pump. These estimates may befurther improved or optimized by comparing a flow rate derived using thepre-loaded values (e.g., the flow rate determined using task 980 of FIG.9) to a corresponding measured flow rate, such as a flow rate measuredby an ultrasonic flow meter. The difference between the derived flowrate and the measured flow rate corresponds to an error in thepre-loaded values. The pre-loaded values may then be adjusted, such asby increasing or decreasing T and/or increasing or decreasing S, inorder to reduce the error. The process of deriving a flow value based onthe then-current fiducial F(BEMF) values, comparing that value to ameasured flow rate value, and updating the fiducial F(BEMF) values maybe repeatedly performed until the error is minimized or maintained at aminimum value. The error may be considered minimized or at a minimumvalue when the estimated flow is within ±1.5 LPM of the measured flow.In one such example, the pump may be considered optimized when the erroris considered minimized for one or more of the speeds of the operationof the pump. In another example, the optimization process may beimplemented using multiple pumps, with mean F(BEMF) values beingacquired from each of the pumps at one or more of the speeds ofoperation. All of the pumps may be considered optimized when the errorfor each pump lies inside a predefined tolerance interval (e.g., ±1.5LPM). The outcome of reducing the error would be an optimized flowestimation algorithm.

A blood pump system 1000 in accordance with yet another embodiment ofthe invention incorporates an active control system comprising an activecontrol module which exerts an axial force on the rotor to counteractthe effects of thrust on the rotor and maintain the rotor in asubstantially constant axial position. Further examples of activecontrol systems are provided in U.S. Published Patent Application No.20110237863, entitled “Magnetically Levitated Blood Pump WithOptimization Method Enabling Miniaturization.”

System 1000 comprises a pump 1001 and control circuit 1070. The pump1001 comprises a rotor 1020 disposed within housing 1010 and actuated bya stator 1030. The rotor 1020 comprises coils 1030. Unlike the pump 101(FIG. 1), the pump 1001 (FIG. 10) also comprises electromagnets 1040 a-bfor producing a magnetic field which exerts an axial force on rotor 1020that is opposite in direction and similar in magnitude to the thrustimparted on the rotor 1020 by the flow of blood impelled by the pump1001. The force produced by the electromagnets balances out the thrustand allows the rotor 1020 to remain in place.

Control circuit 1070 may include an active control module 1072 and flowdetermination module 1070. The active control module 1072 may receiveinput signal(s) 1050 and outputs control signal(s) 1060. In thisexample, the control signal 1060 controls the magnitude of the magneticfield produced by at least one of the electromagnets 1040 a-b. Thecontrol signal 1060 may be a digital directed to a controller thatoperates the electromagnets 1040 a-b, an analog current used to powerthe electromagnets 1040 a-b, or any other signal. Because the controlsignal 1060 sets the magnitude of the magnetic field of theelectromagnets 1040 a-b, which is used to offset the thrust imparted onthe rotor 100 by the flow of blood output by the pump 101, the controlsignal bears a direct relationship to the thrust.

The signal 1060 constitutes another example of a parameter related tothrust and it may be used to determine blood flow rate. The flowdetermination module 1074 may determine the blood flow rate produced bythe pump 1001 by receiving the control signal 1060 and matching it to acorresponding blood flow rate. For example, a table may be stored in amemory of the control circuit 140 that relates different values for thecontrol signals 1040 to blood flow rate. Here again, the table mayinclude different sets of data for different pump operating speeds andblood viscosities. The flow determination module 1074 may use the tableto match the value of the control signal 1060 to a corresponding bloodflow rate.

In still other arrangements, thrust can be measured directly. Forexample, if the pump includes a bearing which retains the rotor againstaxial movement, the bearing may incorporate a piezoelectric element orother force transducer. The signal from the force transducer, or afunction of the signal, may be used as the parameter related to thrust.

In the embodiment discussed above with reference to FIGS. 1-9, theparameter F(BEMF) related to thrust is used to select a portion of thecurrent-to-flow relationship 610 (FIG. 6), i.e., the left or rightportion of the curve. In a variant of this approach, the system candetermine flow directly from F(BEMF) using the F(BEMF)-to-flow table 534(FIG. 5 and Table 2, above) whenever the value of F(BEMF) is below thefiducial midpoint T, and determine the flow based on the right portionof the current-to-flow relationship 610 when F(BEMF) is above thefiducial midpoint T. In one such variant, the first blood flow ratevalue (task 960) may be determined directly from F(BEMF), and the secondblood flow rate value (task 970) may be determined from the rightportion of curve 610. The blood flow rates determined from F(BEMF) andthe right portion of curve 610 may then be combined (task 980). Inanother variant, each of three blood flow rate values may be determined:(1) directly from F(BEMF); (2) from the left portion of curve 610; and(3) from the right portion of curve 610. These three values may then becombined (e.g., first averaging values 1 and 2, and then averaging thefirst average with value 3 using Formula 2) to determine the blood flowrate of the pump.

As a further alternative, the system can limit determinations of flowdirectly from F(BEMF) to circumstances in which the value of BEMF issignificantly less than the fiducial midpoint T (i.e., less than T−S).As another alternative, the system can further limit determinations offlow directly from F(BEMF) to circumstances in which: (i) the value ofBEMF is significantly less than the fiducial midpoint T; and (ii) thespeed of rotation of rotor 120 (e.g., determined by the speeddetermination module 330) is less than 18 kRPM.

In the particular system discussed above with reference to FIGS. 1-9,the relationship between F(BEMF) and flow is such that for values abovethe threshold, the slope of curve 620 becomes relatively small. In thisregion, a large change in flow corresponds to only a small change inF(BEMF). This makes it difficult to determine the flow accurately fromF(BEMF). However, in other systems having different rotor and coilconfigurations, the relationship between F(BEMF) and flow provides moresubstantial variation of F(BEMF) per unit change in flow rate over theentire range of flow rates to be monitored. In those cases, the flowrate can be determined based solely on F(BEMF), without reference to thecurrent used by the pump. Likewise, where another parameter related tothrust is employed, the determination of flow rate can be based solelyon such other parameter. In yet another alternative, a parameter relatedto thrust, such as F(BEMF), can be used without use of thecurrent-to-flow relationship even where the parameter is useful overonly a limited range of flow rates. For example, using the same F(BEMF)as employed in FIGS. 1-9, the system can detect occlusion or suctionevents by comparing the value of F(BEMF) with a relatively lowthreshold, well below the fiducial midpoint T in FIG. 6. In thisarrangement, F(BEMF) is used as a parameter for control or monitoring ofthe pump without converting it to a value of flow rate. For example, thesystem may be arranged simply to issue an alarm signal, or take someother predetermined action, whenever F(BEMF) falls below a threshold orremains below the threshold for a particular time. Similar strategiescan be used with other parameters related to thrust. In another variant,the system can evaluate the flow rate associated with F(BEMF) andcompare that value to a low threshold, below the normal operating rangeof flow rates.

The control circuit 140 need not store relationships between a parametersuch as F(BEMF) and flow or between current and flow in the form oflookup tables as discussed above. The control circuit may retrieve andevaluate a formula that models the rate at which blood is impelled bythe pump as a function of the parameter related to thrust, e.g., aformula for the function 620 (FIG. 6). Likewise, the control circuit mayretrieve and evaluate a formula for the current-to-flow relationship,e.g., a formula of the function 610.

In the embodiments discussed above, the flow rate determined by thecontrol circuit is used to control the operation of the pump. In otherembodiments, the control circuit may simply determine the flow rate andsend a signal representing the flow rate to an external device, and maynot control operation of the pump.

FIGS. 7-9 are provided as examples. At least some of the tasksassociated with FIGS. 7-9 may be performed in a different order thanrepresented, performed concurrently or altogether omitted.

In the embodiment discussed above in connection with FIGS. 6-9,computation of flow rate is based on a weighting parameter that is aparticular function of BEMF, namely the rate of change or slope of theBEMF during open phase periods. However, other functions of BEMF may beused as a weighting parameter. For example, the function of BEMF may besimply the magnitude of BEMF detected. Stated another way, as used inthis disclosure the expression “function of BEMF” includes BEMF itselfas well as other functions of BEMF. Use of a function of BEMF as aparameter for flow rate determination is particularly advantageousbecause it is not necessary to incorporate any additional transducerinto the pump. In effect, the coils of the pump act as the transducer tomeasure BEMF and thus measuring displacement of the rotor and,indirectly, measuring thrust on the rotor.

Other parameters related to thrust on the rotor may be employed insteadof a function of BEMF. For example, where the pump is equipped with atransducer other than the coils which can directly measure the axialposition of the rotor, control circuit 140 may determine the flow ratebased in whole or in part on a signal from the transducer whichrepresents displacement. Stated another way, the displacement is aparameter related to thrust on the rotor. Any other parameter related tothrust on the rotor can be used.

More generally, while the above embodiments use a weighting parameterrelated to thrust on the rotor to determine a blood flow rate of a pump,any parameter that increases or decreases monotonically over the rangeof operable flow rates for the pump may be used. In other words, as longas a parameter is a monotonic function of operable flow rates for thepump, that parameter may be used to make a determination as to whetherthe pump is operating on the left or right portion of curve 610 and/or arelative certainty of that determination. Furthermore, any parameterthat increases or decreases monotonically over even a subset of therange of operable flow rates for the pump may be used. For example, ifthe parameter is a monotonic function of flow rates for which there isuncertainty whether the pump is operating on the left or right portionof curve 610, that parameter may be used at least to determine therelative certainty of whether the pump is operating on the left or rightportion.

Further aspects of this disclosure are described in the disclosuretitled “Fiducial Point Optimization,” which is attached.

As these and other variations and combinations of the features discussedabove can be utilized without departing from the subject matter asdefined by the claims, the foregoing description of exemplary aspectsshould be taken by way of illustration rather than by way of limitationof the subject matter as defined by the claims. It will also beunderstood that the provision of the examples described herein (as wellas clauses phrased as “such as,” “e.g.,” “including” and the like)should not be interpreted as limiting the claimed subject matter to thespecific examples; rather, the examples are intended to illustrate onlysome of many possible aspects.

What is claimed is:
 1. A method for monitoring operation of animplantable blood pump, the method comprising: determining an amount ofcurrent supplied to the pump; determining a first flow rate value and asecond flow rate value based on the amount of current supplied to thepump; and determining a flow rate of blood based on a combination of thefirst and second flow rate values and a weighting parameter; andassigning to at least one from the group consisting of the first andsecond flow rate values a weight based at least in part on a determinedrelationship between the weighting parameter and a predeterminedthreshold value.
 2. The method of claim 1, wherein the implantable bloodpump includes a housing having an axis and a rotor disposed within thehousing and rotatable around the axis, and wherein the weightingparameter is related to thrust on the rotor along the axis.
 3. Themethod of claim 1, wherein the weighting parameter at least one ofincreases and decreases monotonically over the range of operable flowrates for the pump.
 4. The method of claim 1, wherein the assignedweight for the first flow rate value is inversely proportionate to therelationship between the weighting parameter and the predeterminedthreshold value, and the assigned weight for the second flow rate valueis proportionate to the relationship between the weighting parameter andthe predetermined threshold value.
 5. The method of claim 1, furthercomprising: calculating an absolute difference between the weightingparameter and a predetermined threshold value; comparing said absolutedifference to a predetermined spread value; and wherein the flow rate ofblood based is determined based on a combination of the first and secondflow rate values when the absolute difference between the thirdparameter and a predetermined threshold value is less than thepredetermined spread value.
 6. The method of claim 5, furthercomprising: determining a speed of rotation of the rotor; and comparingthe determined speed to a threshold value, wherein when absolutedifference is greater than the predetermined spread value, the thirdparameter is less than the predetermined threshold value: the flow rateof blood is determined based on the first flow rate value when thedetermined speed is greater than the threshold value, and when thedetermined speed is less than the threshold speed value, the flow rateof blood is determined based on the third parameter and neither of thefirst and second flow rate values.
 7. A control circuit for monitoringthe operation of an implantable blood pump, the control circuitcomprising: a current determination circuit configure to determine anamount of current supplied to the pump; a flow rate value determinationcircuit configure to determine a first flow rate value and a second flowrate value based on the amount of current supplied to the pump; atransformation circuit configured to determine a weighting parameter;and a flow rate determination circuit configure to determine a flow rateof blood through the pump based on a at least one from the groupconsisting of the first and second flow rate values and the weightingparameter, the flow rate determination circuit being further configuredto: determine a relationship between the weighting parameter and apredetermined threshold value; and determine a respective weight foreach of the first and second flow rate values based on the relationship.8. The control circuit of claim 7, wherein the implantable blood pumpincludes a housing having an axis and a rotor disposed within thehousing and rotatable around the axis, and wherein the weightingparameter is related to thrust on the rotor along the axis.
 9. Thecontrol circuit of claim 7, wherein the weight for the first flow ratevalue is inversely proportionate to the relationship between theweighting parameter and the predetermined threshold value, and theweight for the second flow rate value is proportionate to therelationship between the weighting parameter and a predeterminedthreshold value.
 10. The control circuit of claim 7, wherein the flowrate determination circuit is further operative to: calculate anabsolute difference between the third parameter and a predeterminedthreshold value; and compare the absolute difference to a predeterminedspread value, wherein the flow rate determination circuit determines theflow rate of blood based on a combination of the first and second flowrate values when the absolute difference between the third parameter anda predetermined threshold value is less than the predetermined spreadvalue.
 11. The control circuit of claim 10, wherein the flow ratedetermination circuit is further operative to: determine the flow rateof blood based on the first flow rate value and not the second flow ratevalue when absolute difference is greater than the spread value, and theweighting parameter is less than the predetermined threshold value; anddetermine the flow rate of blood based on the second flow rate value andnot the first flow rate value when the absolute difference is greaterthan a spread value, and the weighting parameter is greater than thepredetermined threshold value.
 12. A control circuit as in claim 10,further comprising a speed determination circuit operative to determinea speed of rotation of the rotor, wherein the flow rate determinationcircuit is further operative to: compare the determined speed to apreselected threshold value; determine the flow rate of blood based onbased on the weighting parameter and neither of the first and secondflow rate values when the absolute difference is greater than a spreadvalue, the weighting parameter is less than the predetermined thresholdvalue and the determined speed is less than the threshold value.